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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device antibodies, anti-cyclic citrullinated peptide (ccp)
Regulation Description Rheumatoid factor immunological test system.
Definition The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.
Product CodeNHX
Regulation Number 866.5775
Device Class 2


Premarket Reviews
ManufacturerDecision
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 6
Device alarm system issue 1
Incorrect or inadequate result 1
Total Device Problems 8

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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